Drug Delivery Balloon Apparatus and Methods for Use

ABSTRACT

A drug delivery balloon apparatus is disclosed herein, comprising: (a) at least two lumens, comprising a first lumen and a second lumen, (b) a balloon inflation port in fluid communication with the first lumen, (c) a drug delivery port in fluid communication with the second lumen, (d) a guidewire port in fluid communication with the second lumen, wherein the second lumen is configured to receive both a guidewire and a drug solution, (e) an occlusion balloon, (f) a drug delivery balloon, where the occlusion balloon and the drug delivery balloon are in fluid communication with the first lumen, (g) one or more drug delivery channels extending the length of the second lumen, and (h) one or more drug delivery ducts extending from the one or more drug delivery channels to an exterior surface of the second lumen.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional applicationSer. No. 15/458,783 entitled “Drug Delivery Balloon Apparatus andMethods for Use”, filed on Mar. 14, 2017, which is a continuation ofU.S. Non-Provisional application Ser. No. 14/244,126 entitled “DrugDelivery Balloon Apparatus and Methods for Use”, filed on Apr. 3, 2014,which claims the benefit of the filing date of U.S. ProvisionalApplication No. 61/809,176 entitled “Drug Delivery Balloon Apparatus &Methods for Use,” filed on Apr. 5, 2013, the contents of each of whichare hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

Local drug delivery is the process by which therapeutic agents aredelivered to specific areas within the vasculature of a human or animalpatient. This localized treatment permits an increased concentration ofthe drug or therapeutic agent at the intended target area but avoidstoxicity that may result through general systemic delivery within thecirculatory system. Known localized drug delivery methods includedrug-eluting stents or balloons, porous drug infusion balloons anddirect catheter delivery.

SUMMARY OF THE INVENTION

The present invention is directed to methods and apparatus for thedelivery of a drug solution or a therapeutic agent to a selected sitewithin the vascular system using a drug delivery balloon apparatus. Thedrug delivery balloon apparatus of the present invention maybeneficially permit an increased balloon length that may be up to fourtimes longer than that of other known balloons providing the advantageof treating larger injury sites in a single procedure. The drug deliveryballoon apparatus of the present invention may also provide a pluralityof grooves for receiving the drug solution during delivery to the targetpassage. These grooves may beneficially guide the flow of the drugsolution through the target passage, while at the same time slowing thedrug flow to increase the amount of time that the drug is in contactwith the wall of the target passage. The drug delivery balloon apparatusand its associated channels also can help to minimize the volume of drugsolution required by occupying a portion of the luminal volume. Inaddition, the drug delivery balloon apparatus may further include anocclusion balloon that may inflate upstream from the drug deliveryballoon to permit adequate pressure to be maintained in the systemduring infusion to effectively advance the drug or therapeutic agentinto and along the plurality of grooves on the outer surface of the drugdelivery balloon. The occlusion balloon also helps to prevent peripheralwashout by blocking blood flow from the treatment area.

Thus, in a first aspect, the present invention provides a drug deliveryballoon apparatus comprising: (a) at least two lumens, comprising afirst lumen and a second lumen, (b) a balloon inflation port incommunication with the first lumen, (c) a drug delivery port incommunication with the second lumen, (d) a guidewire port incommunication with either the second lumen or a third lumen, (e) anocclusion balloon, (f) a drug delivery balloon, wherein an outer surfaceof the drug delivery balloon defines a plurality of grooves extendingfrom a first end of the drug delivery balloon to a second end of thedrug delivery balloon, wherein the occlusion balloon is disposed betweenthe drug delivery balloon and the balloon inflation port, wherein theocclusion balloon and the drug delivery balloon are in communicationwith the first lumen, (g) one or more drug delivery channels extendingthe length of the second lumen, (h) one or more drug delivery ductsextending from the one or more drug delivery channels to an exteriorsurface of the second lumen, and wherein the one or more drug deliveryducts are defined only in a portion of the second lumen that is disposedbetween the occlusion balloon and the drug delivery balloon.

In one embodiment, the invention provides that the plurality of groovesmay be axially aligned with a central axis of the drug delivery balloon.In various other embodiments, the plurality of grooves may be spiraled,helical, substantially straight, sinusoidal, or cross-hatched, forexample. Further, in one example, the drug delivery port may be branchedsuch that two, three, four or more different drug solutions or othersolutions may be introduced into the drug delivery port. In anotherembodiment, the invention may provide that the one or more drug deliverychannels comprises four channels and each drug delivery channel may bein communication with three drug delivery ducts such that there are atotal of twelve drug delivery ducts.

In a second aspect, the present invention also provides a method foradministering at least one drug to a subject in need thereof using adrug delivery balloon apparatus, the method comprising: (a) introducingthe drug delivery balloon apparatus according to the first aspect of theinvention to a target passage, (b) inflating the occlusion balloon andthe drug delivery balloon, (c) injecting a drug solution into the drugdelivery port, and (d) advancing the drug solution through the secondlumen to the one or more drug delivery ducts into the target passage inthe subject and then into and along a plurality of grooves defined in anouter surface of the drug delivery balloon.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of drug delivery balloon apparatus, in accordancewith one embodiment of the invention.

FIG. 1B is a front cross-sectional view of a two lumen configuration ofthe drug delivery balloon apparatus, in accordance with one embodimentof the invention.

FIG. 1C is a front cross-sectional view of a three lumen configurationof the drug delivery balloon apparatus, in accordance with oneembodiment of the invention.

FIG. 1D is a side view of the occlusion balloon and the drug deliveryballoon of the drug delivery balloon apparatus, in accordance with oneembodiment of the invention.

FIG. 1E is a detail cross-sectional side view of the drug deliveryballoon, in accordance with one embodiment of the invention.

FIG. 2 is a flow chart depicting functions that can be carried out inaccordance with example embodiments of the disclosed methods.

DETAILED DESCRIPTION OF THE INVENTION

Exemplary methods and systems are described herein. It should beunderstood that the word “exemplary” is used herein to mean “serving asan example, instance, or illustration.” Any embodiment or featuredescribed herein as “exemplary” is not necessarily to be construed aspreferred or advantageous over other embodiments or features. Theexemplary embodiments described herein are not meant to be limiting. Itwill be readily understood that certain aspects of the disclosed systemsand methods can be arranged and combined in a wide variety of differentconfigurations, all of which are contemplated herein.

Furthermore, the particular arrangements shown in the Figures should notbe viewed as limiting. It should be understood that other embodimentsmay include more or less of each element shown in a given Figure.Further, some of the illustrated elements may be combined or omitted.Yet further, an exemplary embodiment may include elements that are notillustrated in the Figures.

As used herein, with respect to measurements, “about” means+/−5%.Further, as used herein, “target passage” refers to the blood vessel orartery in which the drug delivery balloon is deployed to effectivelyadminister a drug solution. The target passage may further includeartificial lumens used, for example, as teaching aids.

In addition, as used herein, “drug solution” refers to any flowablematerial that may be administered into a target passage. When the drugsolution comprises a therapeutic to be administered to a subject, anysuitable drug that can be administered in solution can be used. Invarious non-limiting embodiments, the therapeutic may comprisesirolimus, heparin, and cell-based therapies; and antineoplastic,anti-inflammatory, antiplatelet, anticoagulant, antifibrin,antithrombin, antimitotic, antibiotic, antiallergic and antioxidantsubstances. Examples of such antineoplastics and/or antimitotics includepaclitaxel, (e.g., TAXOL® by Bristol-Myers Squibb Co., Stamford, Conn.),docetaxel (e.g., Taxotere®, from Aventis S.A., Frankfurt, Germany),methotrexate, azathioprine, vincristine, vinblastine, fluorouracil,doxorubicin hydrochloride (e.g., Adriamycin® from Pharmacia & Upjohn,Peapack N.J.), and mitomycin (e.g., Mutamycin® from Bristol-Myers SquibbCo., Stamford, Conn.). Examples of such antiplatelets, anticoagulants,antifibrin, and antithrombins include aspirin, sodium heparin, lowmolecular weight heparins, heparinoids, hirudin, argatroban, forskolin,vapiprost, prostacyclin and prostacyclin analogues, dextran,D-phe-pro-arg-chloromethylketone (synthetic antithrombin), dipyridamole,glycoprotein IIb/IIIa platelet membrane receptor antagonist antibody,recombinant hirudin, and thrombin inhibitors such as Angiomax a (Biogen,Inc., Cambridge, Mass.). Examples of such cytostatic orantiproliferative agents include angiopeptin, angiotensin convertingenzyme inhibitors such as captopril (e.g., Capoten® and Capozide® fromBristol-Myers Squibb Co., Stamford, Conn.), cilazapril or lisinopril(e.g., Prinivil® and Prinzide® from Merck & Co., Inc., WhitehouseStation, N.J.), calcium channel blockers (such as nifedipine),colchicine, proteins, peptides, fibroblast growth factor (FGF)antagonists, fish oil (omega 3-fatty acid), histamine antagonists,lovastatin (an inhibitor of HMG-CoA reductase, a cholesterol loweringdrug, brand name Mevacor® from Merck & Co., Inc., Whitehouse Station,N.J.), monoclonal antibodies (such as those specific forPlatelet-Derived Growth Factor (PDGF) receptors), nitroprusside,phosphodiesterase inhibitors, prostaglandin inhibitors, suramin,serotonin blockers, steroids, thioprotease inhibitors,triazolopyrimidine (a PDGF antagonist), and nitric oxide. An example ofan antiallergic agent is permirolast potassium. Other therapeuticsubstances or agents which may be appropriate agents include cisplatin,insulin sensitizers, receptor tyrosine kinase inhibitors, carboplatin,alpha-interferon, genetically engineered epithelial cells, steroidalanti-inflammatory agents, non-steroidal anti-inflammatory agents,antivirals, anticancer drugs, anticoagulant agents, free radicalscavengers, estradiol, antibiotics, nitric oxide donors, super oxidedismutases, super oxide dismutases mimics,4-amino-2,2,6,6-tetramethylpiperidine-1-oxyl (4-amino-TEMPO),tacrolimus, dexamethasone, ABT-578, clobetasol, cytostatic agents,prodrugs thereof, co-drugs thereof, and a combination thereof. Othertherapeutic substances or agents may include rapamycin and structuralderivatives or functional analogs thereof, such as40-O-(2-hydroxy)ethyl-rapamycin (known by the trade name of EVEROLIMUS),40-O-(3-hydroxy)propyl-rapamycin,40-O-[2-(2-hydroxy)ethoxy]ethyl-rapamycin, methyl rapamycin, and40-O-tetrazole-rapamycin. In addition, non-therapeutic fluids, such aswater, may be used, if the drug delivery balloon apparatus is being usedin a teaching model or training demonstration, for example.

In a first aspect, FIG. 1A illustrates an example drug delivery balloonapparatus 100 in accordance with one embodiment of the invention. Thedrug delivery balloon apparatus 100 may include three ports: (1) aballoon inflation port 102 that inflates both an occlusion balloon 104and a drug delivery balloon 106, (2) a drug delivery port 108 throughwhich a drug solution is administered, and (3) a guidewire port 110 forreceiving a guidewire and the inflated occlusion balloon 104 and drugdelivery balloon 106. In one example embodiment as shown in FIG. 1A, thedrug delivery port 108 may be bifurcated, such that two, three, four ormore different drug solutions or other solutions may be introduced intothe drug delivery port 108 as deemed appropriate for treatment.

In one example, the three ports lead to two parallel lumens 112. FIG. 1Billustrates a front cross-sectional view of the two lumens. The balloonapparatus 100 may include a first lumen 114 in communication with theballoon inflation port 102 and may be configured to receive a salinecontrast mixture, or any other suitable fluid medium, to inflate theocclusion balloon 104 and the drug delivery balloon 106. Further, theballoon apparatus 100 may include a second lumen 116 in communicationwith the drug delivery port 108 and the guidewire port 110. In oneembodiment, the second lumen 116 may be sized and shaped to receive adrug solution. In one embodiment, the second lumen 116 may also be sizedand shaped to receive a guidewire having a diameter in the range fromabout 0.25 mm to about 1 mm, and preferably in a range from about 0.254mm to about 0.9652 mm. In one embodiment, the first lumen 114 and thesecond lumen 116 may be enclosed in a sheath 118. The second lumen 116may include one or more drug delivery channels 120 extending the lengthof the second lumen 116. These drug delivery channels 120 may be used totransport the drug solution from the drug delivery port 108 to a targetpassage. The second lumen 116 may also include a guidewire channel 122extending the length of the second lumen 116. In another example, thesecond lumen 116 may include a single channel for both the guidewire anddrug solution.

In such a configuration, the guidewire may be removed after use so thatthe drug solution can pass through the second lumen 116. In operation,the balloon apparatus 100 may be configured to infuse the drug solutionwhile the guidewire is in the second lumen 116. In such a configuration,the second lumen 116 would have a larger diameter than the guidewirefrom a location between the guidewire port 110 and the drug deliveryport 108 until just distal to the drug delivery ducts 146. The secondlumen 116 would shrink down to about the diameter of the guidewire justdistal to the drug delivery ducts 146 to the distal end of the balloon.Further, the second lumen 116 would shrink down to about the diameter ofthe guidewire proximal to the drug delivery port 108, so as to preventthe drug solution from exiting the guidewire port 110. In anotherexample, a flange or one-way valve may be used to prevent the drugsolution from exiting the guidewire port 110. Other configurations arepossible as well.

In another embodiment, the three ports may be coupled to threeconcentrically aligned lumens 124. For example, FIG. 1C illustrates afront cross-sectional view of the three lumens 124. As shown in FIG. 1C,the three concentrically aligned lumens 124 comprise an inner lumen 126,a middle lumen 128, and an outer lumen 130, where the first lumen isarranged as the inner lumen, the second lumen is arranged as the middlelumen and the third lumen is arranged as the outer lumen. The innerlumen 126 may be in communication with the guidewire port 110 and may besized and shaped to receive a guidewire having a diameter in the rangefrom about 0.25 mm to about 1 mm, and preferably in a range from about0.254 mm to about 0.9652 mm. The middle lumen 128 may be incommunication with the drug delivery port 108. The middle lumen 128 mayinclude a plurality of flexible spacers 132 that extend between theinner lumen 126 and the outer lumen 130 to maintain the structuralintegrity of the middle lumen 128. These spacers 132, in combinationwith the middle lumen 128 and the inner lumen 126, may further defineone or more drug delivery channels 134 extending the length of themiddle lumen 128. As discussed above, these drug delivery channels 134may be used to transport the drug solution from the drug delivery port108 to a target passage. The outer lumen 130 may be in communicationwith the balloon inflation port 102. The outer lumen 130 may alsoinclude a plurality of flexible spacers 136 to help maintain thestructural integrity of the outer lumen 130. These spacers 136, incombination with the outer lumen 130 and middle lumen 128, may alsodefine a plurality of fluid delivery channels 138 extending the lengthof the outer lumen 130. These fluid delivery channels 138 may be influid communication with the occlusion balloon 104 and the drug deliveryballoon 106.

FIG. 1D illustrates the occlusion balloon 104 and the drug deliveryballoon 106 of the drug delivery balloon apparatus 100. The occlusionballoon 104 may be composed of atraumatic compliant materials such aspolyurethane, latex, or silicone, among other possibilities, thatresults in a low burst pressure of about 5 atm, for example. However,the occlusion balloon 104 may be configured to withstand greaterpressures, for example up to about 20 atm. The occlusion balloon 104 maybe configured to conform to the shape and size of the target passage vialow pressure inflation, about 1 to 2 atm. Once inflated, the occlusionballoon 104 may provide occlusion in the target passage to allow fordrug delivery into the target passage downstream from the occlusionballoon 104 to minimize dilution of the drug solution from blood flow.The inflated diameter of the occlusion balloon 104 may range from about2.5 mm to about 12 mm and is preferably in a range from about 2.5 mm toabout 6 mm. The length of the occlusion balloon 104 may range from about20 mm to about 40 mm. In one embodiment, the inflated diameter of theocclusion balloon 104 ranges from about the same as the inflateddiameter of the drug delivery balloon 106 to about 2 mm larger than theinflated diameter of the drug delivery balloon 106. In operation, theocclusion balloon 104 may be inflated prior to the introduction of thedrug solution into the drug delivery port 108.

The drug delivery balloon 106 may be made of compliant materials such aspolyurethane, latex, or silicone that results in a low burst pressure ofabout 5 atm, for example. The length of the drug delivery balloon 106may range from about 20 mm to about 200 mm. In various embodiments, thelength of the drug delivery balloon 106 ranges from about 80 mm to about200 mm, from about 100 mm to about 200 mm, from about 120 mm to about200 mm, from about 140 mm to about 200 mm, from about 160 mm to about200 mm, from about 180 mm to about 200 mm, from about 60 mm to about 120mm, from about 60 mm to about 100 mm, and from about 10 mm to about 80mm. In one embodiment, the drug delivery balloon 106 may have aninflated diameter ranging from about 2.5 mm to about 12 mm and ispreferably in a range from about 2.5 mm to about 6 mm. In variousembodiments, the inflated diameter of the drug delivery balloon 106 mayrange from about 2.5 mm to about 3 mm, from about 4 mm to about 5 mm,and from about 5 mm to about 6 mm.

The outer surface of the drug delivery balloon 106 may define aplurality of grooves 140 for receiving the drug solution. These grooves140 may extend from the first end 142 to the second end 144 of the drugdelivery balloon 106. The plurality of grooves 140 may serve to (1)guide the flow of the drug solution and (2) slow the flow of the drugsolution to increase the time of contact of the drug with the wall ofthe target passage. The plurality of grooves 140 are preferably axiallyaligned with a central axis of the drug delivery balloon 106 and may bespiraled, helical, sinusoidal or substantially straight, among otherpossibilities, in various embodiments. Spiraled, helical or sinusoidalgrooves are preferred over straight grooves, because the more tortuousgrooves provide more surface area to contact the vessel wall and furtherextend the amount of time that the drug solution contacts the vesselwall. Further, any pattern of grooves is contemplated including across-hatched or waffle pattern, for example.

The occlusion balloon 104 may be disposed between the drug deliveryballoon 106 and the balloon inflation port 102 such that both theocclusion balloon 104 and the drug delivery balloon 106 may be incommunication with the second lumen 116 or the outer lumen 130 andreceive fluid from the balloon inflation port 102. The occlusion balloon104 and the drug delivery balloon 106 may be separated from each otherby a distance ranging from about 1 mm to about 10 mm, and preferablyfrom about 3 mm to about 5 mm. This distance allows adequate pressure tobe maintained in the system such that the drug solution may beeffectively advanced into and along the plurality of grooves 140 on theouter surface of the drug delivery balloon 106.

One or more drug delivery ducts 146 may extend from the one or more drugdelivery channels 120 defined in the second lumen 116 to an exteriorsurface of the second lumen 116. These drug delivery ducts 146 may bedefined in a portion 148 of the second lumen 116 that is disposedbetween the occlusion balloon 104 and the drug delivery balloon 106. Inother words, these drug delivery ducts 130 may be downstream from theocclusion balloon 104 in operation. In one embodiment, the one or moredrug delivery channels 120 may comprise four to eight channels. Inanother embodiment, the one or more drug delivery channels 120 is eachin fluid communication with one to six drug delivery ducts 146. In afurther embodiment, the one or more drug delivery channels 120 maycomprise four channels and each drug delivery channel may be in fluidcommunication with three drug delivery ducts such that there are a totalof twelve drug delivery ducts. The number of drug delivery ducts maydepend upon the length of portion 148 of the second lumen 116 extendingbetween the occlusion balloon 104 and the drug delivery balloon 106and/or the diameter of the drug delivery ducts 146, among otherpossibilities.

FIG. 1E illustrates a cross-sectional side view of the drug deliveryballoon 106. As shown in FIG. 1E, the drug delivery balloon 106 includesa plurality of grooves 140. In operation, the drug solution advancesdownstream into and along the plurality of grooves 140 defined in theouter surface of the drug delivery balloon 106. Once the drug solutionexits the plurality of grooves 140 at the second end 144 of the drugdelivery balloon 106, the drug solution may be cleared via normalarterial blood flow and ultimate physiological function.

FIG. 2 is a simplified flow chart illustrating a method according to anexemplary embodiment. Although the blocks are illustrated in asequential order, these blocks may also be performed in parallel, and/orin a different order than those described herein. Also, the variousblocks may be combined into fewer blocks, divided into additionalblocks, and/or removed based upon the desired implementation.

At block 202, the method involves introducing the drug delivery balloonapparatus according to any of the foregoing embodiments to a targetpassage. The drug delivery balloon apparatus may be introduced anddelivered in a standard coaxial manner, via over-the-wire or rapidexchange techniques, as examples.

At block 204, the method involves inflating the occlusion balloon andthe drug delivery balloon. In one embodiment, the occlusion balloon andthe drug delivery balloon may be inflated by injecting a saline contrastmixture, for example, into the balloon inflation port. The salinecontrast mixture may then be advanced through a first lumen to theocclusion balloon and the drug delivery balloon until both balloons areinflated. The occlusion balloon may inflate at a slightly faster rate,since the occlusion balloon and the drug delivery balloon are connectedin series such that the occlusion balloon receives the saline contrastinflation mixture first. In another embodiment, the occlusion balloonand drug delivery balloon may be inflated using any other suitable fluidmedium.

After both the occlusion balloon and the drug delivery balloon have beeninflated, the method continues at block 206 with injecting a drugsolution into the drug delivery port. In one embodiment, the drugdelivery port is bifurcated, such that two, three, four or moredifferent drug solutions or other solutions may be introduced into thedrug delivery port as deemed appropriate.

At block 208, the method involves advancing the drug solution through asecond lumen to the one or more drug delivery ducts into a targetpassage in the subject. At this stage, the space between the occlusionballoon and the drug delivery balloon acts as a reservoir storing thedrug solution as it is delivered via the drug delivery ducts. Due to thepressure at which the drug solution is being introduced to the drugdelivery port, the drug solution advances downstream into and along theplurality of grooves defined in the outer surface of the drug deliveryballoon. The pressure at which the drug solution is administered shouldnot exceed about 2 atm. Once the drug solution exits the plurality ofgrooves at the second end of the drug delivery balloon, the drugsolution may be cleared via normal arterial blood flow and ultimatephysiological function.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.All embodiments within and between different aspects of the inventioncan be combined unless the context clearly dictates otherwise. Thevarious aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopeand spirit being indicated by the following claims.

1. A drug delivery balloon apparatus comprising: at least three lumens,comprising a first lumen, a second lumen, and a third lumen; a ballooninflation port in fluid communication with the first lumen; a drugdelivery port in fluid communication with the second lumen; a guidewireport in fluid communication with the third lumen; an occlusion balloon;a drug delivery balloon, wherein an outer surface of the drug deliveryballoon defines a plurality of grooves extending from a first end of thedrug delivery balloon to a second end of the drug delivery balloon,wherein the occlusion balloon is disposed between the drug deliveryballoon and the balloon inflation port, wherein the occlusion balloonand the drug delivery balloon are in fluid communication with the firstlumen; one or more drug delivery channels extending a length of thesecond lumen; and one or more drug delivery ducts extending from the oneor more drug delivery channels to an exterior surface of the secondlumen, and wherein the one or more drug delivery ducts are defined onlyin a portion of the second lumen that is disposed between the occlusionballoon and the drug delivery balloon.
 2. The drug delivery balloonapparatus of claim 1, wherein the first lumen, the second lumen and thethird lumen are concentrically aligned such that the third lumen isarranged as an inner lumen, the second lumen is arranged as a middlelumen, and the first lumen is arranged as an outer lumen.
 3. The drugdelivery balloon apparatus of claim 2, further comprising: a firstplurality of spacers extending between the inner lumen and the outerlumen configured to maintain a structural integrity of the middle lumen,wherein the first plurality of spacers in combination with the middlelumen and the inner lumen define the one or more drug delivery channelsextending the length of the second lumen.
 4. The drug delivery balloonapparatus of claim 3, wherein the outer lumen includes a secondplurality of spacers configured to maintain a structural integrity ofthe outer lumen, wherein the second plurality of spacers in combinationwith the outer lumen and the middle lumen define a plurality of fluiddelivery channels extending a length of the outer lumen.
 5. The drugdelivery balloon apparatus of claim 1, wherein the plurality of groovesare axially aligned with a central axis of the drug delivery balloon. 6.The drug delivery balloon apparatus of claim 1, wherein the plurality ofgrooves are spiraled, helical, substantially straight, sinusoidal, orcross-hatched.
 7. The drug delivery balloon apparatus of claim 1,wherein the occlusion balloon and the drug delivery balloon areseparated from each other by a distance ranging from about 3 mm to about5 mm.
 8. The drug delivery balloon apparatus of claim 1, wherein thedrug delivery port is bifurcated.
 9. The drug delivery balloon apparatusof claim 1, wherein the occlusion balloon and the drug delivery ballooneach have an inflated diameter ranging from about 2.5 mm to about 12 mm.10. The drug delivery balloon apparatus of claim 9, wherein the inflateddiameter of the occlusion balloon ranges from about the same as theinflated diameter of the drug delivery balloon to about 2 mm larger thanthe inflated diameter of the drug delivery balloon.
 11. The drugdelivery balloon apparatus of claim 1, wherein the occlusion balloonranges in length from about 20 mm to about 40 mm.
 12. The drug deliveryballoon apparatus of claim 1, wherein the drug delivery balloon rangesin length from about 50 mm to about 200 mm.
 13. The drug deliveryballoon apparatus of claim 1, wherein the drug delivery balloon is about200 mm in length.
 14. The drug delivery balloon apparatus of claim 1,wherein the guidewire port is sized to receive a guidewire, and whereinthe guidewire has a diameter ranging from about 0.25 mm to about 1 mm.15. The drug delivery balloon apparatus of claim 1, wherein the one ormore drug delivery channels comprises four to eight channels.
 16. Thedrug delivery balloon apparatus of claim 1, wherein the one or more drugdelivery channels is each in fluid communication with one to six drugdelivery ducts of the one or more drug delivery ducts.
 17. The drugdelivery balloon apparatus of claim 1, wherein the one or more drugdelivery channels comprises four channels and each drug delivery channelis in fluid communication with three drug delivery ducts such that thereare a total of twelve drug delivery ducts.
 18. A method foradministering at least one drug to a subject in need thereof using adrug delivery balloon apparatus, the method comprising: introducing thedrug delivery balloon apparatus of claim 1 into a target passage;inflating the occlusion balloon and the drug delivery balloon; injectinga drug solution into the drug delivery port; and advancing the drugsolution through the second lumen to the one or more drug delivery ductsinto the target passage in the subject and then into and along theplurality of grooves defined in an outer surface of the drug deliveryballoon.
 19. The method of claim 18, wherein injecting the drug solutionis performed at a fluid pressure at or below 2 atm.
 20. The method ofclaim 18, wherein an inflated diameter of the occlusion balloon rangesfrom about the same as the inflated diameter of the drug deliveryballoon to about 2 mm larger than the inflated diameter of the drugdelivery balloon.
 21. The method of claim 18, wherein inflating theocclusion balloon and the drug delivery balloon comprises: injecting asaline contrast mixture into the balloon inflation port; and advancingthe saline contrast mixture through the first lumen to the occlusionballoon and the drug delivery balloon.